To compare the effectiveness of aspirin and aspririnmetformin combination preventing preeclampsia in high risk pregnant women with abnormal ultrasonic findings in uterine artery a randomized clinical trial
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Protocol summary
In our research,we will select161high risk pregnant women for preterm labor based on first trimester Doppler sonography,then with block randomizing method we will place them on two groups.161patient will receive aspirin& Metformin and other group will receive aspirin&placebo.Treatment starts since11-13week of pregnancy until34 week or delivery time.
In our research,we will select161high risk pregnant women for preclampsia based on first trimester Doppler sonography,then with block randomizing method we will place them on two groups.161patient will receive aspirin& Metformin and other group will receive aspirin&placebo.Treatment starts since11-13week of pregnancy until34 week or delivery time.
In our research,we will select161high risk pregnant women for preterm laborpreclampsia based on first trimester Doppler sonography,then with block randomizing method we will place them on two groups.161patient will receive aspirin& Metformin and other group will receive aspirin&placebo.Treatment starts since11-13week of pregnancy until34 week or delivery time.
در این مطالعه 161مادر باردار که بر اساس سونوگرافی داپلر سه ماه اول در گروه پر خطر برای زایمان زودرس هستند انتخاب می شوند و با نسبت1:1و توسط روش بلوک بندی تصادفی با بلوک های 4تایی و 6تایی به دو گروه دریافت کننده آسپیرین&متفورمین و آسپرین& پلاسبو تقسیم می شوند و درمان با آسپیرین از هفته 13-11شروع می شود و تا هفته 34یا زمان زایمان ادامه می یابد.
در این مطالعه 161مادر باردار که بر اساس سونوگرافی داپلر سه ماه اول در گروه پر خطر برای پره اکلامپسی هستند انتخاب می شوند و با نسبت1:1و توسط روش بلوک بندی تصادفی با بلوک های 4تایی و 6تایی به دو گروه دریافت کننده آسپیرین&متفورمین و آسپرین& پلاسبو تقسیم می شوند و درمان با آسپیرین از هفته 13-11شروع می شود و تا هفته 34یا زمان زایمان ادامه می یابد.
در این مطالعه 161مادر باردار که بر اساس سونوگرافی داپلر سه ماه اول در گروه پر خطر برای زایمان زودرسپره اکلامپسی هستند انتخاب می شوند و با نسبت1:1و توسط روش بلوک بندی تصادفی با بلوک های 4تایی و 6تایی به دو گروه دریافت کننده آسپیرین&متفورمین و آسپرین& پلاسبو تقسیم می شوند و درمان با آسپیرین از هفته 13-11شروع می شود و تا هفته 34یا زمان زایمان ادامه می یابد.
Prevention of preterm labor and decrease fetal mortality and morbidity due to preterm labor
Prevention of preclampsia and decrease fetal mortality and morbidity due to preclampsia
Prevention of preterm laborpreclampsia and decrease fetal mortality and morbidity due to preterm laborpreclampsia
پیشگیری از زایمان زودرس؛کاهش مورتالیتی و موربیدیتی های نوزادی ناشی از زایمان زودرس
پیشگیری از پره اکلامپسی؛کاهش مورتالیتی و موربیدیتی های نوزادی ناشی از پره اکلامپسی
پیشگیری از زایمان زودرسپره اکلامپسی؛کاهش مورتالیتی و موربیدیتی های نوزادی ناشی از زایمان زودرسپره اکلامپسی
General information
empty
correction some words
correction some words
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اصلاح چند کلمه
اصلاح چند کلمه
The singleton pregnant women who are high risk for uteroplacental ischemia and preterm labor based on increased uterine artery resistant on first trimester doppler ultarasonography.
The singleton pregnant women who are high risk for uteroplacental ischemia and preclampsia based on increased uterine artery resistant on first trimester doppler ultarasonography.
The singleton pregnant women who are high risk for uteroplacental ischemia and preterm laborpreclampsia based on increased uterine artery resistant on first trimester doppler ultarasonography.
مادران با بارداری تک قلو که در هفته 11 + 0 تا 13 + 6 تحت سونوگرافی داپلر قرار گرفته اند و بر اساس معیارهای سونوگرافیک و مقاومت شریان رحمی در معرض خطر بالای ابتلا به ایسکمی رحمی جفتی و زایمان زودرس قرار دارند
مادران با بارداری تک قلو که در هفته 11 + 0 تا 13 + 6 تحت سونوگرافی داپلر قرار گرفته اند و بر اساس معیارهای سونوگرافیک و مقاومت شریان رحمی در معرض خطر بالای ابتلا به ایسکمی رحمی جفتی و پره اکلامپسی قرار دارند
مادران با بارداری تک قلو که در هفته 11 + 0 تا 13 + 6 تحت سونوگرافی داپلر قرار گرفته اند و بر اساس معیارهای سونوگرافیک و مقاومت شریان رحمی در معرض خطر بالای ابتلا به ایسکمی رحمی جفتی و زایمان زودرسپره اکلامپسی قرار دارند
Protocol summary
Study aim
To compare the effectiveness of aspirin and aspririn metformin combination preventing preeclampsia in high risk pregnant women with abnormal ultrasonic findings in uterine artery
Design
In our research,we will select161high risk pregnant women for preclampsia based on first trimester Doppler sonography,then with block randomizing method we will place them on two groups.161patient will receive aspirin& Metformin and other group will receive aspirin&placebo.Treatment starts since11-13week of pregnancy until34 week or delivery time.
Settings and conduct
Between all pregnant women who will come to educational hospital in Shiraz city,322 person who are high risk based on first trimester Doppler sono will be selected and they will be assigned in two groups with block randomizing method.Group1will receive aspirin&metformin and the other will receive aspirin&placebo.Finally the results between two groups will be compared.It needs to be mentioned that all tablets will be used in two groups have the same shape ,color and size.The staff of research center has the list of randomized and grouping and tablets,and she will give drugs to the patients.
Participants/Inclusion and exclusion criteria
The singleton pregnant women who are high risk for utero-placental ischemia according to increased uterine artery resistant in first trimester Doppler sono.Exclusion criteria:Multiple pregnancy;Fetal aneuploidy;Fetal anomaly;Coagulation disorder;Allergy to aspirin
Intervention groups
Group A patients are prescribed two Aspirin 80 tablets made by Jalinous Pharmaceutical Company and two placebo tablets(placebo will be made by the Faculty of Pharmacy of SUMS)and for Group B two Aspirin80 tablets made by Jalinous Pharmaceutical Company and two Metformin tablets of500ml are prescribed.
Main outcome variables
Prevention of preclampsia and decrease fetal mortality and morbidity due to preclampsia
General information
Reason for update
correction some words
Acronym
IRCT registration information
IRCT registration number:IRCT20140317017035N9
Registration date:2024-05-18, 1403/02/29
Registration timing:prospective
Last update:2024-05-23, 1403/03/03
Update count:1
Registration date
2024-05-18, 1403/02/29
Registrant information
Name
Maryam Kasraeian
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 32365
Email address
kasraeem@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-21, 1403/03/01
Expected recruitment end date
2025-01-20, 1403/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
To compare the effectiveness of aspirin and aspririnmetformin combination preventing preeclampsia in high risk pregnant women with abnormal ultrasonic findings in uterine artery a randomized clinical trial
Public title
Effectiveness of aspirin and aspririnmetformin combination preventing preeclampsia
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
The singleton pregnant women who are high risk for uteroplacental ischemia and preclampsia based on increased uterine artery resistant on first trimester doppler ultarasonography.
Exclusion criteria:
Multiple pregnancy
Fetal aneuploidy
Fetal anomaly
Allergy to aspirin
Women who use aspirin or heparin before starting study
Coagulation disorder
Age
From 18 years old to 45 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
322
Randomization (investigator's opinion)
Randomized
Randomization description
In our research ,we will select 322 high risk pregnant women for preeclampsia based on first trimester doppler sonography ,then with block randomizing method we will place them on two groups. 161 patient will receive aspirin & pelacbo and other group will receive Metformine & aspirin .treatment starts since 11-13 week of pregnancy until 34 week or delivery time(each one occur sooner.)
Blinding (investigator's opinion)
Double blinded
Blinding description
All tablet use in two groups are the same shape , color and size. Patients and doctors are unaware about dosages that is choosed in each person. The nurse of research center has the list of randomized and grouping and tablets and she will give drugs to the patients.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Cmmittee of Shiraz University of Medical Sciences
Street address
Headquarters Of Shiraz University of Medical Sciences, Zand St, Shiraz
City
Shiraz
Province
Fars
Postal code
7194643786
Approval date
2024-04-13, 1403/01/25
Ethics committee reference number
IR.SUMS.REC.1403.047
Health conditions studied
1
Description of health condition studied
Preeclampsia
ICD-10 code
O14
ICD-10 code description
Pre-eclampsia
Primary outcomes
1
Description
Decrease fetal mortality and morbidity due to preeclampsia
Timepoint
After birth
Method of measurement
Vital Signs
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Aspirin 160 mg and metformin 1000 mg
Category
Treatment - Drugs
2
Description
Control group: Aspirin with a dose of 160 mg and placebo
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Haspial affilatd to Shiaz university of medical sciences
Full name of responsible person
Fateme Shaitinia
Street address
Building of Shiraz University of Medical Sciences, Zand Ave
City
Shiaz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3647 9830
Email
fshariati85@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hashem Hashempour
Street address
Building of Shiraz University of Medical Sciences, Zand Ave
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3235 7282
Email
hashempurm@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fateme Shartinia
Position
Fellowship
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Maternal- Fetal Medicine (Perinatology), Hafez Hospital, Chamran Ave., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3647 9830
Email
fshariati85@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Kasraeian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Maternal- Fetal Medicine (Perinatology), Hafez Hospital, Chamran Ave., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
00887136479830
Email
mayamkasraian@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Maryam Kasraeian
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Gynecology and Obstetrics
Street address
Maternal- Fetal Medicine (Perinatology), Hafez Hospital, Chamran Ave., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
34786-71946
Phone
+98 71 3647 9830
Email
maryamkasraeian@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Not applicable
Title and more details about the data/document
Information and research data Ethic form: Complete the ٍEthic form by the patient
When the data will become available and for how long
IPD: 2024و Ethic form: 2024
To whom data/document is available
IPD: Researcher & Patient Ethic form: Patient
Under which criteria data/document could be used
IPD: Ethic form: Awareness of test results
From where data/document is obtainable
IPD: OB & Gyn ward Shiraz university of medical sciences Ethic form: OB & Gyn ward Shiraz university of medical sciences
What processes are involved for a request to access data/document